Tamper evident syringe barrel

ABSTRACT

A prefilled syringe of cartridge barrel having a tamper evident closure. Tamper evidence is provided by: a frangible tip seal which is integral with the tapered tip of the barrel; a frangible tip cap covering the tip, the tip seal and a portion of the distal end of the barrel; and an overwrap covering the frangible tip cap and the distal end of the barrel sealed to the distal end of the barrel by a tamper evident seal. The tapered tip is optionally equipped with a luer collar to receive an external luer connector. Alternatively, the tapered tip can be provided with a bore therethrough which can be closed with an elastomeric plug and the external connector can be a tubing conduit.

This application is a continuation of U.S. application Ser. No.10/774,852, filed Feb. 9, 2004, now U.S. Pat. No. 6,846,303 which is adivisional of U.S. application Ser. No. 10/265,986, filed Oct. 7, 2002,now U.S. Pat. No. 6,726,652, which is a divisional of U.S. applicationSer. No. 09/759,565, filed Jan. 12, 2001, now U.S. Pat. No. 6,485,460,all of which are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to a tamper evident cap for a prefilledsyringe barrel. More particularly, the invention relates to a tip cappositioned on the distal end of the prefilled syringe barrel and anoverwrap enclosing the tip cap and at least a portion of the prefilledsyringe barrel.

BACKGROUND OF THE INVENTION

Hypodermic syringes are well-known in the prior art comprising: acylindrical syringe body having a fluid-receiving chamber therein; aproximal end; and a distal end. The distal end of the syringe bodytapers into a tip having a bore therethrough which communicates with thefluid-receiving chamber. The tip is covered with a closure means such asa stopper of a polymeric or elastomeric material, a tip cap or amembrane to prevent leakage and contamination of the fluid medicationcontained in the syringe barrel. The closure means must be able to beremoved with relative ease when the prefilled syringe is to be used.

A plunger is inserted into the open proximal end of the syringe barrelfor sliding in fluid-tight engagement with the inside wall of thefluid-receiving chamber. The plunger is equipped with a plunger rod toenable the user to exert pressure on the plunger.

The hypodermic syringe also includes a needle cannula, packagedseparately from the syringe barrel, which has a proximal end attachableto the tip of the syringe barrel, and a distal end terminating in asharp or blunt point. Some hypodermic syringes are equipped with a luerconnector to be attached to a corresponding luer collar on the syringebarrel. Additionally, flexible tubing can be placed between thehypodermic syringe and a needle cannula with luer connectors at bothends.

It has been observed that during in-line processing, handling, andsterilizing of the prefilled barrels, some polymeric or elastomericclosures were missing from the lips of the barrels resulting in rejects.Also, during shipment of the finished product and handling by healthcareprofessionals some untipped barrels were observed which necessitateddiscarding of batches containing failed samples. For product integrity acorrective measure was indicated to prevent the polymeric or elastomericclosure from becoming dislodged from the tip of the barrel.

More importantly, it has also been recognized that untipped barrels,whether the damage occurred during shipment or handling, attracts thesuspicion that the product was tampered with. Such possible tampering isa concern for both the National Regulating Authorities and themanufacturers who are required to insure safety, efficacy and theproduct integrity.

The prior art has provided various tamper evident closures for syringes.

One reference discloses a tamper evident syringe characterized in thatthe syringe barrel, the cap, and the plunger rod are covered with atubular sealing device that is made from a heat-shrinkable film andwhich has been shrunk under heat so that it adheres closely to thesurfaces of those members.

The sealing device comprises a tube and a tear tape. The tube is formedof a transparent heat-shrinkable film. The tear tape is attached bybonding to the inner surface of the tube from one end to the other inthe longitudinal direction.

Another reference discloses a hypodermic syringe used with a needle forlyophilized medicament comprising: a syringe body having a pistontherein equipped with a tip cap at its distal end; an elastomeric plughaving a passage channel closing the neck of the syringe; and aprotector cap which encloses the tip cap and the neck portion of thesyringe body. The protector cap and tip cap are integral with each otherand can be moved axially to open and close the syringe. The protectorcap consists of a top portion and a bottom portion, the two parts beingheld together by a weakened portion. The center of the protector cap isprovided with a small hole through which the tip cap can be viewed. Inuse, the top portion of the protector cap is snapped off at the weakenedportion, and the tip cap is taken off and discarded. A needle is thenfitted in the passage channel of the elastomeric plug to access thecontent of the syringe.

Still another reference discloses a syringe cap assembly placed on thedistal end of a syringe. The assembly includes: an elastomeric inserthaving a passage therein; a retaining collar which fits over theelastomeric insert to hold the insert in place; a plug or tip cap isengaged in the insert to block the passage in the insert; and aretaining safety cap fitted over the tip cap. The end wall of theretaining safety cap is formed with a hole in its center and is slightlysmaller in diameter than the plug so that the user can ascertain thatthe plug is properly in its place without opening the assembly.

In use the safety cap is pulled, twisted, and lifted off the assembly.The plug is then lifted off to expose the collar, and a needle assemblyis fitted to the collar.

A further reference discloses a prefilled syringe with break-away tipseal which closes the passageway to the content of the syringe. A scoremeans is provided adjacent to the tip for accommodating removal of thesealed tip.

An object of the present invention is to provide a prefilled tamperevident syringe or cartridge barrel which makes apparent theunauthorized use of the medical fluid contained in the barrel of thesyringe or cartridge or at least warns healthcare professionals thatsuch unauthorized use may have occurred.

The present invention also addresses the requirement of tailor-makingthe barrel to provide various degrees of protection against tampering,i.e. certain medical fluids such as narcotics, lends a grater incentivefor tampering than other medical fluids, such as a saline solution. Towit, a barrel containing narcotics should have more than one built-intamper evidence, although such an approach can equally apply to othermedicaments.

Another object of the present invention is to provide tamper evidentsyringe or cartridge barrels the content of which is easily accessed bythe healthcare professionals while their unauthorized use is readilyapparent.

A further object of the present invention is to provide a tamper evidentsyringe or cartridge barrel the content of which can be accessed by luerconnections or a tubing conduit so as to avoid the use of “sharps” andthereby preventing needle stick injuries.

SUMMARY OF THE INVENTION

In accordance with the present invention there is provided a prefilledsyringe or cartridge barrel equipped with tamper evident closures whichindicate unauthorized use of the contents of the syringe of cartridgebarrel (hereinafter sometimes referred to as “barrel”). The inventionconsists of four embodiments each of which is designed to be usedwithout sharp or blunt needles so that needle stick injuries as well asthe spread of contagious diseases associated with such injuries areprevented.

In one embodiment the present invention comprises:

-   -   a) a barrel made of glass or a polymeric material, preferably of        transparent polymeric material, containing a medical fluid        therein, the proximal end thereof having a slideable elastomeric        plunger for expelling the medical fluid from the barrel, and the        distal end terminating in a shoulder portion which extends into        a tapered tip, said tapered tip having a bore therethrough for        fluid communication with the medical fluid in the barrel;    -   b) a tamper evident closure on the distal end of the barrel        comprising:    -   1) a tip seal closing the bore and being integral with the        tapered tip, said tip seal having a weakened portion for        breaking off the tip seal when delivery of the medical fluid is        required;    -   2) a luer collar around the tapered tip for connection to an        external luer connector;    -   3) a tip cap covering the distal end of the barrel frangibly        connected to the shoulder of the barrel, said tip cap having a        slot therein designed to be placed on the tip seal to twist off        the tip seal from the tapered tip;    -   4) an overwrap having a horizontal top portion, a distal end and        a proximal end, covering the tip cap, the shoulder of the barrel        and a portion of the barrel; and    -   5) a tamper evident seal having a score line therein to seal the        proximal end of the overwrap to the distal end of the barrel;        wherein a space or gap is provided between the horizontal top        portion of the overwrap and the tip cap to allow grasping the        overwrap and remove the same from the barrel.

In another embodiment of the present invention the tip cap furthercomprises: a centrally positioned cylinder enclosing the tip seal tofacilitate breaking off the tip seal from the tapered tip; and ananti-rotation lock between the distal end of the barrel and the tip cap.In this embodiment, the tip cap consists of two portions: an upperportion separated from the lower portion by a breakaway score line. Theupper portion is designed to be removed while the lower portion remainson the barrel, the shoulder portion and the tapered tip.

The above-described embodiments provide multiple tamper evidence byhaving: a tip seal, a tip cap and a overwrap each of which must beremoved to reach the content of the barrel. These embodiments areintended to prevent tampering with the barrel containing, for example,narcotics or other medicaments.

In the third embodiment the present invention provides a barrel, havinga medical fluid therein, with a tamper evident closure which comprises:

-   -   a tamper evident tip cap frangibly connected to the neck of the        barrel; an elastomeric plug closing the bore in the tip of the        barrel wherein the tip is surrounded by a luer collar; and an        overwrap sealed to the barrel by a tamper evident seal.        Similarly to the above-described embodiments, a gap is provided        between the top portion of the overwrap and the top of the tip        cap to allow grasping of the overwrap and removing the overwrap        from the barrel.

The fourth embodiment of the present invention is essentially the sameas the third embodiment except the luer collar is removed so that noexternal luer connector is needed to tap the content of the barrel.Instead of an external luer connector a tubing conduit is used one endof which is attached to the open tip of the barrel.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional view of a syringe barrel and plungerequipped with a frangible tip seal, a protector tip cap and overwrap;

FIG. 2 is a plan view of the overwrap;

FIG. 3 is a perspective view of the protector tip cap;

FIG. 4 is a cross-sectional view of the protector tip cap taken alongthe line 4—4 of FIG. 3;

FIG. 5 is a partial perspective view of the syringe barrel and theprotector tip cap positioned horizontally on the tip seal during removalof the tip seal at the frangible score line;

FIG. 6 is a partial cross-sectional view of another embodiment of thepresent invention showing the distal end of a syringe barrel, afrangible tip seal, a protective tip cap having two portions, and anoverwrap;

FIG. 7 is a partial cross-sectional view of another embodiment of thepresent invention showing a syringe barrel, a protective tip cap withwidened upper portion, and an overwrap; and

FIG. 8 is a partial perspective view of a syringe barrel, the luercollar and an elastomeric plug covering the tip of the syringe barrel;and

FIG. 9 is a bottom plan view of the elastomeric plug.

DETAILED DESCRIPTION OF THE INVENTION

In the figures, like numbers denote corresponding elements, while likenumbers with prime (′) thereon denote like elements;

FIGS. 1–5 show one embodiment of the present invention.

FIG. 1 shows a prefilled syringe or cartridge barrel, generallydesignated by the numeral 10, made of glass or a polymeric material,having an outside wall 12, an inside wall 14 defining a cylindricalchamber 16 which contains an injectable sterile fluid therein 18, adistal end 20, a proximal end 22, a plunger 24 slideably positioned inthe barrel, and a flange 26 on the proximal end.

At its distal end the barrel terminates in a tapered sealed tipgenerally designated by the numeral 28 and comprises a distal end 27 anda proximal end 29. The sealed tip has a breakaway score means or weakportion 30 adjacent to the tip seal portion for breaking the tip sealportion off the distal end of the barrel to form an opening which, alongwith a bore in the tip seal, forms a passageway through which theinjectable sterile fluid may be expelled by advancing the plunger fromthe proximal end towards the distal end of the barrel. The tip sealprevents the injectable fluid, such as therapeutic and diagnosticsubstances to be expelled prior to it being broken off at the scoremeans or weakened portion as well as preventing the entry ofcontaminants into the sterile injectable fluid contained in the barrel.

The tip seal is surrounded by a cylindrical luer collar 32 havinginternal spiral threads 34 therein for attaching a corresponding IVcatheter thereto having external spiral threads thereon. When the tipseal is detached, an outlet is created which allows fluid communicationbetween the content of the barrel and the IV catheter.

Surrounding the tip seal 28 and the cylindrical luer collar 32 is a tipcap, generally designated by the numeral 36, which at its proximal end38 is sealed to proximal end 29 of the tip seal 28 with a thermoplasticor other suitable material. The seal so formed is frangible so that thetip cap can be easily separated from the tapered tip seal by breakingoff the tip cap.

As shown in FIGS. 1, 3, 4 and 5, tip cap 36 is provided with a slot 40at the proximal end 38 thereof having a width sufficient to accommodatethe tapered tip seal after the tip cap is separated from the tapered tipseal. The steps to provide access to the sterile injectable fluidincludes: breaking off the tip cap 36 from the tip seal 27 at theproximal end 38 of the tip cap 36; placing the tip cap onto the tip sealby putting the tip cap onto the tip seal so that the tip seal ispositioned in the slot of the tip cap; and twisting the tip cap in ahorizontal direction thereby separating the tip cap from the tip seal atthe frangible area 41.

Referring to FIGS. 1 and 2, the distal end 20 of syringe or cartridgebarrel 10 including tip seal 28 and luer collar 32 enclosed within tipcap 36, is further enclosed by an overwrap, generally designated by thenumeral 42. The overwrap having a distal end 44, a proximal end 46 and aside wall 48 of cylindrical configuration closed at its distal end andopen at its proximal end.

The overwrap is made of a polymeric sheet, preferably of two or morelayers superimposed on each other and sealed together at theirperipheries to form a cylindrically shaped body. The inside layer 49 isformed with an overwrap ridge 50 projecting towards the barrel. Theoutside layer 51 of the overwrap is continuous forming the top and sideportions of the overwrap. A tamper evident seal 52 closes the proximalend of the overwrap to the outside wall 12 of the barrel 10. A frangiblescore line 54 running horizontally in the tamper evident seal rendersthe overwrap removable when delivery of the sterile injectable fluid isdesired from the syringe or cartridge barrel.

In covering a portion of the syringe or cartridge barrel, the tip capand tip seal, the overwrap is slid towards the proximal end of thebarrel until overwrap ridge 50 reaches the top tapered portion 11 of thebarrel 10. The overwrap ridge anchors the overwrap to the taperedportion of the barrel. For glass barrels the anchoring is accomplishedby providing a groove in the tapered top portion of the barrel intowhich the plastic ridge snaps. For plastic barrels the anchoring isaccomplished by forming a ridge in the plastic tapered portion of thebarrel. In both cases, when removal of the overwrap is desired, theoverwrap is dislodged from the groove or ridge of the barrel by pullingthe overwrap toward the distal end of the barrel. In reference to FIG.1, it is to be noted that a space 37 is provided between the insidelayer 49 of the overwrap 42 and top portion of tip cap in order to allowgripping the overwrap 42 when removal of same is desired.

As can be seen, this embodiment of the present invention provides aprefilled syringe or cartridge barrel for injection of a sterile medicalfluid where the injection can be accomplished by hand, or a powerinjector such as disclosed, for example, by U.S. Pat. No. 5,322,511. Thetip seal integrally formed with the barrel prevents entry ofcontaminants from contacting the sterile medical fluid in the barrelprior to use or leakage of medical fluid from the barrel. The tip sealalso provides a measure of security that the content of the barrel hasnot be tampered with. However, the present invention also provides moreapparent signs of tampering by the use of a tip cap and an overwrap ascomponents of the present invention. In order to get to the content ofthe barrel: first, the overwrap must be removed leaving the lower orproximal portion thereof on the barrel and showing at the score linethat the overwrap has been removed; second, the tip cap must be removedwhich also leaves a score line on the proximal end of the tip seal; andthird, the top portion of the tip seal must be broken off in order toopen the fluid channel to the content of the barrel.

Another embodiment of the present invention is shown in partialcross-sectional view in FIG. 6 wherein like numerals denotecorresponding elements shown in FIGS. 1–5 except the tip cap having aprime (′) thereon. Additional parts not shown in FIGS. 1–5 are denotedby additional numerals.

Tip cap 36′ comprises two parts: an upper part 56 and a lower part 58.The upper and lower parts are separated form each other by a breakawayscore line 60. The upper part is designed to be broken off while thelower part remains on the syringe or cartridge barrel 10. The upper partcontains a centrally positioned cylinder 62 extending from the top wall39 of the tip cap and terminates at the score line 60. The inside wall64 of centrally positioned cylinder 62 runs parallel to tip seal 28 andis in contact therewith. Cylinder 62 serves to hold tip seal 28 andhelps to remove the tip seal at the weak portion 30 thereof. Lower part58 of tip cap 36′ extend from breakaway score line 60 to and includingthe upper portion of the syringe barrel. The distal end 66 of lower part58 is molded to the syringe barrel by a method known in the art.Additionally, the lower part 58 of tip cap 36′ is provided with ananti-rotation lock 68, made of a polymeric material which holds thesyringe barrel and the lower part of the tip cap together and preventsrotation of the lower part of the tip cap when the upper part of the tipcap is being removed. The anti-rotation lock may be affixed between thesyringe barrel and the tip cap by an adhesive or, preferably, athermoplastic polymer. Most preferably, both the tip cap and theanti-rotation lock are made of thermoplastic materials.

When it is desired to establish fluid communication between the syringebarrel and an external access means, such as an IV set having a luerlock corresponding with the luer collar shown in FIG. 6, the followingsteps must be accomplished: removing the overwrap which encloses aportion of the syringe barrel thereby disclosing the frangible scoreline 54; removing the upper part of the tip cap which disclosesbreakaway score line 60; and removing tip seal 28 by breaking off thesame at weak portion 30. At each step, if the device has been tamperedwith, the healthcare practitioner would be warned of the likelihood oftampering.

FIG. 7 shows, in a partial cross-sectional view, a syringe barrel havinga widened tip cap covering the distal end of the syringe barrel and anoverwrap covering the tip cap and the top portion of the syringe barrel.This embodiment of the present invention is directed to a syringe barrelof simple, inexpensive construction which has a built-in feature thatwarns the healthcare professional that the syringe might have beentampered with.

The syringe barrel 10 comprises: a cylindrical chamber 16 which containsa medical fluid therein; a tapered shoulder 70 extending into neckportion 72 towards the distal end of the syringe. Neck portion 72 atthat distal end thereof is covered with a tip cap 74 which widens into atop portion 76. The widened top portion facilitates removal of the tipcap. Overwrap 78 encloses a portion of the syringe barrel, the shoulder70 of the syringe barrel and the tip cap 74 with its widened top portion76. The overwrap comprises at least two layers of polymeric film:outside layer and inside layer. The inside layer is provided with ridge50′ projecting inwardly towards the shoulder 70 of syringe barrel 10.Space 37′ is provided between the widened portion of tip cap 76 and theinside layer of the overwrap. Tamper evident seal 52′ having frangiblescore line 54′ therein seals the overwrap to the outside wall 12 ofbarrel 10. Tip cap 74 is sealed to neck 72 by an adhesive or athermoplastic means.

FIG. 8 is a fragmentary cross-sectional view of the distal end of thesyringe barrel, luer collar, and elastomeric plug 80. The luer collarand the elastomeric plug are hidden under tip cap 74 in FIG. 7. Thedistal end of the barrel, in this embodiment of the present invention,terminates in a tapered tip having a bore therethrough. The tapered tipis surrounded by cylindrical luer collar 32′ having internal spiralthreads therein. The luer collar is designed to receive an externalaccess means, such as an IV set, with a corresponding luer connection.As seen in FIGS. 8 and 9, elastomeric plug 80 is of cylindricalconfiguration having a distal and a proximal end comprising: a closedportion 82 at the distal end, an open portion at the proximal end,outside wall 84 and inside wall 86 connecting the top and bottomportions. The inside wall defines a cylindrical chamber 88. Theelastomeric plug is positioned within the wall of the luer collar sothat the cylindrical chamber covers the open tip of the syringe barrel.When delivery of the medical fluid is desired the elastomeric plug isremoved.

The tamper evident syringe barrel in this embodiment of the presentinvention is also provided without the luer collar 32′. When delivery ofthe medical fluid is desired the elastomeric plug 80 is removed and oneend of a tubing conduit is attached to the open tip of the barrel. Theother end of the tubing conduit is equipped with a syringe through whichthe medical fluid is administered to the patient.

The method of accessing the medical fluid contained in the syringebarrel includes the steps of:

-   -   removing the tamper evident seal at the score line from the        syringe barrel;    -   removing the overwrap by holding or pulling on the top portion        of the overwrap;    -   removing the tip cap by holding the widened portion thereof and        turning the same in either direction;    -   removing the elastomeric plug from the top of the syringe        barrel;    -   connecting an external access means to the open tip of the        barrel; and    -   advancing the plunger in the barrel in the distal direction.        Materials of Construction

The syringe or cartridge barrel is made of glass or known polymericmaterials, preferably a transparent polymeric material. The barrel canbe coated with a UV barrier coating.

The UV barrier coating is a clear flexible film made of polymers havingUV absorbing (scavenging) or oxygen absorbing (scavenging) properties sothat the content of the container is not affected by environmentalconditions. These polymers include in the form of a film alloys, blends,extrusions, laminations, surface modified and impregnated films orcombinations thereof of the following polymeric materials which arecapable to withstand autoclave or high-temperature sterilization andwhich contain UV absorbing or oxygen scavenging agent or into which suchagents are incorporated by processes known to those skilled in the art:

-   -   copolyester elastomers,    -   ethylene methacrylate,    -   ethylene vinyl acetate,    -   ethylene vinyl alcohol,    -   low density polyethylene,    -   nylon/polypropylene,    -   polyester,    -   polyolefin,    -   polypropylene,    -   polyethylene and    -   polyvinylchloride.

Blocking agents/UV stabilizers which may be included in the filmsinclude:

-   N-(2-Aminoethyl)-3-aminopropylmethyldimethoxy silane;    3-Aminopropylmethyl-diethoxy silane; Amyitrichlorosilane;-   Bis (hydroxyethyl) aminopropyltriethoxy silane;    Bis-(N-methylbenzanide) ethoxymethyl silane;    Bis(trimethylsilyl)acetamide;-   3-Chloropropyltriethoxysilane;-   Di-t-butoxydiacetoxysilane;-   Ethyltriacetoxysilane;-   (3-Glycidoxypropyl)-methyldiethoxy silane;-   Isobutyltrimethoxysilane; Isocyanatopropyltriethoxysilane;-   3-Mercaptopropylmethyldimethoxysilane;    Mercaptopropyltrimethoxysilane; N-methylaminopropyltrimethoxysilane;    Methyltriacetoxysilane; Methyltriethoxysilane;    Methyltrimethoxysilane;-   Octyltriethoxysilane;-   2-Phenylethyltrichlorosilane; Phenyltriethoxysilane;    n-Propyltrimethoxysilane 3-(N-Styrylmethyl-2-aminoethylamino)    propyltrimethoxy silane hydrochlorid;,-   2-(3′-t-butyl-2′-hydroxy-5′-methylphenyl)-5-chlorobenzotriazole, and-   Bis    (1,2,2,6,6,-pentamthyl-4-piperidinyl)(3,5-di-t-butyl-4-hydroxybenzyl)butyl    propanedioate andethyl 2-cyano-3,3-diphenylacrylate.

The protective cap is made of a polymeric material including:polyolefins such as polyethylene and polypropylene; polystyrene,polycarbonate, polymethylpentene, cyclic olefin co-polymers, acrylicpolymers and methacrylic polymers.

The elastomeric plug is preferably of soft rubber.

The overwrap used in the present invention can be a monolayer film,however, multilayer films are preferred. The sheets are made of knownpolymeric materials having properties which make them suitable for useunder conditions of steam and gamma rays sterilization. Such propertiesinclude gloss, strength, flexibility and chemical inertness. Preferably,the sheets are transparent or at least translucent enabling visualinspection of the contents at all times prior to and during delivery ofthe content from the barrel to the patient. The sheets may be made, forexample, from polyvinylidine chloride between two polyethylene orpolyvinyl acetate layers. Further layers may be added to the face orback of the sheet, if desired, such as polyolefin, preferably,polyethylene. Polyvinyl chloride is also suitable for the constructionof the sheet and is well-accepted by the prior art for use in containersfor medical fluid collection and delivery. Typical properties ofpolyvinyl chloride films include: a thickness of about 380 micron; atensile strength of about 240 kg/cm²; a moisture vapor transmission rateof about 14–20 (g/m²/days at 38° C., 100% RH); and an oxygen barrier of650 (cc/m²/day at 23° C., 0% RH, bar. CRYOVAC® sterlizable medical films(W.R. Grace and Co.) are especially suitable to construct the sheetsused in the present invention. The films comprise a polyethylene layerbetween polyester outer layers sealed together by a modified propyleneco-polymer. Typical properties of the film include: a thickness of about190 micron; a tensile strength of about 250 kg/cm²; a moisture vaportransmission rate of 5 (g/m²/day at 38° C., 100% RH); and an oxygenbarrier of about 1500 (cc/m²/day at 23° C., 0% RH, bar).

Other preferred polymeric films or sheets for constructing the flexibleoverwrap of the present invention include: copolyester ether monolayerfilms, such as polycyclohexanedimethylcyclohexane dicarboxylateelastomer made by Eastman Chemical Co.

PARTS LIST

-   Syringe or cartridge barrel, generally designated 10-   Top tapered portion of barrel 11-   Outside wall of barrel 12-   Inside wall of barrel 14-   Cylindrical chamber in barrel 16-   Injectable sterile fluid in barrel 18-   Distal end of barrel 20-   Proximal end of barrel 22-   Plunger in barrel 24-   Flange on barrel 26-   Tip seal, generally designated 27-   Distal end of tip seal 28-   Proximal end of tip seal 29-   Weak portion on tip seal 30-   Cylindrical luer collar on tip seal 32, 32′-   Internal spiral threads on cylindrical luer collar 34, 34′-   Tip cap, generally designated 36, 36′-   Space between top portion of tip cap and inside layer of overwrap    37, 37′-   Proximal end of tip cap 38-   Distal end of tip cap 39-   Slot in tip cap 40-   Frangible area of tip cap sealed to tip seal 41-   Overwrap, generally designated 42, 42′-   Distal end of overwrap 44-   Proximal end of overwrap 46-   Side wall of overwrap 48-   Inside layer of overwrap 49-   Overwrap ridge 50, 50′

PARTS LIST (CONTD.)

-   Outside layer of overwrap 51-   Tamper evident seal 52, 52′-   Frangible score line on tamper evident seal 54, 54′-   Upper part of tip cap 56-   Lower part of tip cap 58-   Breakaway score line between upper part and lower part of tip cap 60-   Centrally positioned cylinder in the upper part of tip cap 62-   Inside wall of cylinder 64-   Distal end of lower part of tip cap 66-   Anti-rotation lock 68-   Shoulder portion of syringe barrel 70-   Neck portion of syringe barrel 72-   Tip cap 74-   Widened portion of tip cap 76-   Overwrap 78-   Elastomeric plug, generally designated 80-   Top portion of elastomeric plug 82-   Outside wall of elastomeric plug 84-   Inside wall of elastomeric plug 86-   Cylindrical chamber in elastomeric plug 88

Having described the invention, it will be apparent to those skilled inthe art that various changes and modifications may be made thereto. Itis intended to include such changes and modification limited only by thescope of the appended claims.

1. A prefilled tamper evident syringe barrel comprising: a) a syringebarrel of glass or polymeric material having an inner surface defining achamber having a medical fluid therein, said syringe barrelcomprising: 1) a distal end comprising: a tapered shoulder, a neckportion and an open tip portion; b) an elastomeric plug closing saidopen tip portion; c) a tip cap of cylindrical configuration having awidened top portion to facilitate the removal thereof, and a bottomportion enclosing said elastomeric plug, and a part of said neck portionof said syringe barrel; wherein said tip cap is sealed to the neckportion by an adhesive or thermoplastic means; d) an overwrap ofcylindrical configuration having a closed distal end and an openproximal end, said overwrap being provided with a ridge adjacent to theproximal end thereof projecting towards the shoulder of said syringebarrel and resting thereon; wherein said overwrap encloses a portion ofsaid syringe barrel, said shoulder portion and said tip cap; and e) atamper evident seal of cylindrical configuration having an open distalend and an open proximal end provided with a frangible score line, whichseals said proximal end of said overwrap to the said syringe barrel;wherein said frangible score line facilitates the removal of saidoverwrap from said syringe barrel.
 2. The prefilled tamper evidentsyringe barrel of claim 1 wherein said tamper evident syringe barrel iscoated with a UV barrier coating.